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临床试验/NCT07404904
NCT07404904
已完成
不适用

Evaluation of the Effects of Therapeutic Touch on Pain, Delirium, Sleep, and Physiological Parameters in Intensive Care Patients

Sibel Oksuz1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年10月10日最近更新:
干预措施therapeutic touch

概览

阶段
不适用
状态
已完成
发起方
Sibel Oksuz
入组人数
80
试验地点
1
主要终点
RCSQ (Richards-Campbell Sleep Questionnaire)

概览

简要总结

The study was conducted to determine the effects of therapeutic touch applied to intensive care patients on pain, delirium, sleep and physiological parameters.

详细描述

This study aims to evaluate the effects of therapeutic touch on pain, delirium, sleep, and physiological parameters in surgical intensive care patients. Patients will be assessed at 24, 48, and 72 hours. The intervention and control groups will be randomized. The intervention group will receive routine care and therapeutic touch, while the control group will receive only routine care. Parameters will be assessed before and after each measurement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Participants do not know which group they are in the study.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who volunteer to participate in the study,
  • Patients aged 18 and over who receive post-surgical treatment at the Surgical Intensive Care Unit of Aksaray Education and Research Hospital,
  • Patients who do not have communication problems (hearing, speaking, understanding, etc.),
  • Patients who have received treatment in the surgical intensive care unit for at least 72 hours,
  • Patients with RASS: between -3 and +4 and Glasgow coma scale: 10 and above,
  • Patients who use only non-steroidal drugs as analgesics,
  • Patients whose medical diagnosis is not dementia,
  • Patients who do not have a mental state disorder/psychological disease and do not use sleeping pills.

排除标准

  • Patients who developed complications in the ICU after surgery,
  • Patients who received treatment in the surgical intensive care unit for less than 72 hours.

研究组 & 干预措施

Randomized control

Experimental

Experimental (therapeutic touch)

干预措施: therapeutic touch (Other)

Control

No Intervention

Control (routine care)

结局指标

主要结局

RCSQ (Richards-Campbell Sleep Questionnaire)

时间窗: At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).

Sleep quality assessed with RCSQ, range 0-100.

Blood pressure

时间窗: At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).

Systolic and diastolic blood pressure measured using standard bedside monitoring in the intensive care unit.

Heart rate

时间窗: At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).

Heart rate measured using continuous bedside cardiac monitoring in the intensive care unit.

Respiratory rate

时间窗: At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).

Respiratory rate measured and recorded as breaths per minute using bedside monitoring.

Body temperature

时间窗: At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).

Body temperature measured using a standard clinical thermometer in the intensive care unit.

Oxygen saturation

时间窗: At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).

Peripheral oxygen saturation measured by pulse oximetry.

RASS (Richmond Agitation and Sedation Scale)

时间窗: At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).

Sedation/agitation level scored from +4 (combative) to -5 (unarousable).

VAS (Visual Analog Scale)

时间窗: At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).

Pain intensity measured using a 0-10 Visual Analog Scale (0 = no pain, 10 = worst pain).

次要结局

  • VAS (Visual Analog Scale)(At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).)
  • RASS (Richmond Agitation and Sedation Scale)(At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).)
  • RCSQ (Richards-Campbell Sleep Questionnaire)(At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).)
  • Blood pressure(At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).)
  • Heart rate(At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).)
  • Respiratory rate(At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).)
  • Body temperature(At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).)
  • Oxygen saturation(At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).)

研究者

发起方
Sibel Oksuz
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sibel Oksuz

Principal Investigator

Aksaray University

研究点 (1)

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